Ksybiz Hyperbarics: September 2018

Wednesday, September 12, 2018

CLASSIFICATIONS OF HYPERBARIC CHAMBERS AS MEDICAL DEVICES

A: FDA Classification of Hyperbaric Chambers :

The definition of a Medical device is given in the FD&C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators. Including Medical Devices and Non Medical Devices

FDA , Food and Drug Administration USA has a separate Section that Classifies the Medical Devices and Hyperbaric Chamber is a Genuine Medical Device and this is done by Subsidiary of called CDRH , The Center for Devices and Radiological Health (CDRH) .. Which is the branch of the FDA responsible for the pre-market approval of all medical devices, as well as overseeing the , manufacturing, performance and safety of these devices.

CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagneticradiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products.

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device, based on Device Class and Regulatory Controls :

The 3 three classes and the requirements which apply to them are:

1. Class I :

With General Controls, Mostly Do not require Controls

2. Class II :

Special Controls With Exemptions or Without Exemptions Requiring 510K required , If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.

3. Class III :

General Controls and Requiring Pre-market Approval , For Class III devices, a Pre-market approval application (PMA) will be required unless your device is a Pre-amendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) The class to which your device is assigned determines, among other things, the type of Pre-marketing submission/application required for FDA clearance to market.

Hyperbaric Chamber is Classified as Class 2 by FDA .

B : NFPA National Fire Protection Association USA :

The National Fire Protection Association (NFPA) is a United States trade association, albeit with some international members, that creates and maintains private, copyrighted standards and codes for usage and adoption by local governments. The association was formed in 1896 by a group of insurance firms.

NFPA , Grades the Chambers into following Categories :

A: Mono Chambers

B: Multi-places Chambers

C: Special Chambers like used for Veterinary Purposes

Ksybiz Hyperbarics

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Wednesday, September 12, 2018

CLASSIFICATIONS OF HYPERBARIC CHAMBERS AS MEDICAL DEVICES

A: FDA Classification of Hyperbaric Chambers :

B : NFPA National Fire Protection Association USA :

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